Factor 1: Data management	PBRN does this well	PBRN has an SOP	Area to improve	Priority: low; medium; or high
1.1. The PBRN has procedures in place to keep research data for the time specified by NIH and IRB regulations. For example, NIH requires that data be retained for 3 years after study completion.
1.2. Research data and documentation are stored in a secure location.
1.3. Electronic data are frequently stored on fire‐walled and password‐protected hardware.
1.4. Data analyses are conducted in collaboration with a person knowledgeable about statistical analyses.
1.5. Paper records are kept in locked enclosures.
1.6. All steps of the data management process are documented. For example, logging file names, printouts, variables and file changes.
1.7. The PBRN uses data management protocols for the examination and resolution of outliers.
1.8. The PBRN uses data management protocols to promote accurate data entry. For example, all or some proportion of data are double‐coded or double‐entered to check for outliers or errors.
1.9. The PBRN uses data management protocols such as random audits for errors.
1.10. Research staff members periodically receive professional development and training that is tailored to their research responsibilities.
Factor 2: Study supervision
2.1. Study orientations include a discussion on the importance of following the study protocol in order to maintain uniformity at all sites participating in a multiple‐site study.
2.2. During study orientation, the staff are clearly explained their roles and responsibilities in the study.
2.3. During the study orientation, clinical staff are trained in how to carry out the study in a manner consistent with research ethics.
2.4. Study managers (site coordinators or PBRN managers) use quality control mechanisms in order to maintain the integrity of research data. For example, conducting random audits, holding regular meetings with staff to review study operations and data collection procedures.
Factor 3: PBRN policies	PBRN does this well	PBRN has an SOP	Area to improve	Priority: low; medium; or high
3.1. Study managers (site coordinators or PBRN managers) emphasize the importance of integrity in data collection and record‐keeping to clinical staff members.
3.2. The site supervisors facilitate or promote the work climate as supportive to research by making sure clinic staff have the time required to do a conscientious job on the study.
3.3. PBRN management assures that all staff members with research responsibilities understand the importance of their role in the research process. For example, staff members are encouraged to participate in discussions of study implementation.
3.4. The PBRN clarifies authorship policies at the start of each study.
3.5. The PBRN clarifies publication policies at the start of each study. For example, investigators do not publish from PBRN studies independently unless permitted by the PBRN.
3.6. Sometimes network clinicians and staff expect to be included as co‐authors. The PBRN clearly addresses expectations and criteria for authorship at the beginning of the study.
3.7. The PBRN clarifies data agreements at the start of each study regarding data ownership. For example, investigators do not analyze or publish from PBRN studies independently unless permitted by the PBRN.
3.8. The PBRN clarifies data analysis policies at the start of each study.
3.9. The PBRN has a data agreement (either its own or that of a professional organization) on the dissemination of results, including publications and presentations.
Factor 4: Study Management	PBRN does this well	PBRN has an SOP	Area to improve	Priority: low; medium; or high
4.1. The PI, the PBRN study manager, the site coordinator and clinical staff communicate on a regular basis during the course of the study to address progress. For example, the Principal Investigators and staff discuss and agree upon their mutual responsibilities.
4.2. Site staff members are encouraged to discuss study questions and concerns with the site coordinator and/or PBRN study manager.
4.3. Each clinical site has a designated site coordinator who assists the PBRN study manager in the implementation of the research study. For example, the PBRN study manager and site supervisors monitor study progress on an ongoing basis.
4.4. Prior to beginning or launching a new study, the PBRN consults with clinic staff to assure that they have sufficient time to complete the project.
4.5. For each site, there is a study champion who is responsible for promoting the study to staff members.
Factor 5: Ethical considerations
5.1. Study managers (site coordinators or PBRN managers) monitor the informed consent process, and assure that consent forms are completed for each study participant. For example, the consent process can be monitored with a random audit to determine if signed consent forms are on file for each enrolled participant.
5.2. The PBRN study manager monitors clinic staff education in human subjects protections to assure that all staff participating in the study have received the required training.
5.3. The PBRN is vigilant in looking out for scientific misconduct.

SOP = standard operating procedure.